Victoza

liraglutide

Opinion

On 27 June 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Victoza. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S.

The CHMP adopted a change to the existing indication as follows: 1

“Victoza is indicated for the treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

  • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
  • in addition to other medicinal products for the treatment of diabetes.

For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold

Key facts

Name
Victoza
Agency product number
EMEA/H/C/001026
International non-proprietary name (INN) or common name
  • liraglutide
Active substance
  • liraglutide
Therapeutic area
Diabetes Mellitus, Type 2
Date opinion adopted
27/06/2019
Company name
Novo Nordisk A/S
Status
Positive
Application type
Post-authorisation

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